AzTrials
AzTrials

Brain and Central Nervous System TumorsNCT00349024

Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer

A study testing polyvinylpyrrolidone-sodium hyaluronate gel in people with Brain and Central Nervous System Tumors and Chordoma, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis, or mouth sores, in patients undergoing treatment for cancer. PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with… Read more about this study

Who is it for?
Ages 4 to 19 years
What is being tested?
polyvinylpyrrolidone-sodium hyaluronate gel
How many people
50 participants
Where
21 sitesin 2 countries
Study dates
Jul 2005to Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer, including, but not limited to, the following:
  • Acute lymphoblastic leukemia
  • Acute myeloid leukemia
  • Brain tumor
  • Hodgkin's lymphoma
  • Non-Hodgkin's lymphoma
  • Sarcoma
  • Wilms' tumor
  • Neuroblastoma
  • Meets 1 of the following criteria:
  • Admitted to an in-patient unit after undergoing chemotherapy that is anticipated to cause oral mucositis
  • Admitted to an in-patient unit after undergoing myeloablative therapy followed by peripheral blood stem cell or bone marrow transplantation
  • Is experiencing oral pain due to mucositis

PATIENT CHARACTERISTICS:

  • No known hypersensitivity to polyvinylpyrrolidone-sodium hyaluronate gel

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent analgesics allowed

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United Kingdom20 sites

  • Royal Aberdeen Children's Hospital

    Aberdeen, Scotland, AB25 2ZG

  • Royal Belfast Hospital for Sick Children

    Belfast, Northern Ireland, BT12 6BE

  • Birmingham Children's Hospital

    Birmingham, England, B4 6NH

  • Institute of Child Health at University of Bristol

    Bristol, England, BS2 8AE

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Childrens Hospital for Wales

    Cardiff, Wales, CF14 4XW

  • Royal Hospital for Sick Children

    Edinburgh, Scotland, EH9 1LF

  • Royal Hospital for Sick Children

    Glasgow, Scotland, G3 8SJ

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Liverpool Children's Hospital, Alder Hey

    Liverpool, England, L12 2AP

  • Middlesex Hospital

    London, England, W1T 3AA

  • Great Ormond Street Hospital for Children

    London, England, WC1N 3JH

  • Royal Manchester Children's Hospital

    Manchester, England, M27 4HA

  • Sir James Spence Institute of Child Health at Royal Victoria Infirmary

    Newcastle upon Tyne, England, NE1 4LP

  • Queen's Medical Centre

    Nottingham, England, NG7 2UH

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Children's Hospital - Sheffield

    Sheffield, England, S10 2TH

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Ireland1 site

  • Our Lady's Hospital for Sick Children Crumlin

    Dublin, 12

Other trials in Ireland

About this study

Official title: Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)

RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis, or mouth sores, in patients undergoing treatment for cancer.

PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer.

Read the detailed description

OBJECTIVES:

  • Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy.

OUTLINE: This is a prospective, uncontrolled, open-label, pilot, multicenter study.

Beginning before hospital discharge or day 3 after chemotherapy, patients use oral polyvinylpyrrolidone-sodium hyaluronate gel mouth rinse for at least 1 minute, 3 times per day or as needed. Treatment continues for 48 hours. Patients with persistent oral pain may continue treatment with polyvinylpyrrolidone-sodium hyaluronate gel beyond 48 hours.

Oral pain and acceptability (i.e., taste) of polyvinylpyrrolidone-sodium hyaluronate gel are assessed periodically using self-reported rating scales.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Being tested
polyvinylpyrrolidone-sodium hyaluronate gel
Keywords
unspecified childhood solid tumor, protocol specific, pain, childhood acute lymphoblastic leukemia, childhood Hodgkin lymphoma, chondrosarcoma, osteosarcoma, childhood soft tissue sarcoma, Wilms tumor and other childhood kidney tumors, neuroblastoma, childhood acute myeloid leukemia/other myeloid malignancies, childhood large cell lymphoma, childhood lymphoblastic lymphoma, childhood small noncleaved cell lymphoma, childhood rhabdomyosarcoma, childhood brain stem glioma, childhood central nervous system germ cell tumor, childhood cerebellar astrocytoma, childhood cerebral astrocytoma/malignant glioma, childhood choroid plexus tumor, childhood craniopharyngioma
Medical subject headings
Central Nervous System Neoplasms, Chordoma, Kidney Neoplasms, Leukemia, Lymphoma, Mucositis, Neuroblastoma, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • polyvinylpyrrolidone-sodium hyaluronate gelDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timing and intensity of oral pain

  2. Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel

  3. Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel

  4. Symptoms, other than pain, considered important to the pediatric population

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00349024
Sponsor's protocol ID
CDR0000481526
Other IDs
CCLG-SC-2005-07, EU-20621
Status last verified
Jun 2009
First submitted
5 Jul 2006
Last updated
20 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing polyvinylpyrrolidone-sodium hyaluronate gel in people with Brain and Central Nervous System Tumors and Chordoma, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timing and intensity of oral pain. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00349024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in